Key Players in Medical Device Regulation: Economic Operators under EU MDR and IVDR
In the rapidly evolving landscape of medical device regulations, understanding the roles and responsibilities of economic operators is...
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- 3 days ago
- 3 min
Navigating Regulatory Gray Areas: Borderline Devices in the EU MDR and IVDR Era
In the world of medical devices, categorization and classification are essential processes that determine how products are regulated and...
- 4 days ago
- 3 min
Class I Medical Devices and CE Marking: Compliance Essentials
The European Union (EU) boasts one of the most stringent regulatory frameworks for medical devices in the world. For manufacturers...
- 5 days ago
- 5 min
Navigating the Complex World of Combination Products: Understanding EU MDR Article 117
In the world of healthcare, many patients benefit from the use of combination products – medical devices that incorporate pharmaceuticals...
- 6 days ago
- 4 min
Certifying Medical Devices in the EU: The Crucial Role of Notified Bodies under MDR and IVDR
In the ever-evolving world of medical devices, Notified Bodies play a pivotal role in ensuring the safety and efficacy of products...
- 7 days ago
- 4 min
The CE Mark is Just the Beginning: Post-CE Compliance under EU MDR
The introduction of the European Union Medical Device Regulation (EU MDR) 2017/745 marked a significant milestone in the world of medical...
- Sep 25
- 4 min
EU MDR Compliance: Navigating the Essential EUDAMED Modules
The European Medical Devices Regulation (EU MDR) has ushered in a new era of regulations for medical devices in the European Union. Among...
- Sep 24
- 6 min
Deciphering Medical Device Risk Classification Under EU MDR
The European Union Medical Device Regulation (EU MDR) represents a significant overhaul of the regulatory framework for medical devices...
- Sep 23
- 5 min
Navigating the EU MDR Labelling Requirements: A Comprehensive Guide
The European Union Medical Device Regulation (EU MDR) has ushered in a new era of regulatory compliance for medical device manufacturers....
- Sep 22
- 4 min
Regulation of Reusable Medical Devices under EU MDR
The introduction of the EU Medical Device Regulation (MDR) has brought increased emphasis on robust data and comprehensive evaluations...
- Sep 21
- 7 min
Understanding System and Procedure Packs in Accordance with EU MDR
In the realm of modern healthcare, the role of system and procedure packs cannot be overstated. These packs serve as invaluable tools,...
- Sep 18
- 4 min
Understanding the CE Marking Process for Medical Devices in the EU
The CE (Conformité Européenne) mark is a critical certification for medical devices seeking approval within the European Union. It...
- Sep 17
- 8 min
Regulation of Reprocessed Single-Use Devices (SUD) under EU MDR
"Reprocessing" denotes a series of procedures conducted on a previously used device to enable its safe reuse. This encompasses cleaning,...
- Sep 16
- 4 min
Essential Considerations for Reprocessing Single-Use Devices in Accordance with EU MDR
Essential Considerations for Reprocessing Single-Use Devices in Accordance with EU MDR Single-Use Devices (SUDs) are indispensable in the...
- Sep 15
- 4 min
Conformity Assessment of Medical Devices under EU MDR
The world of medical devices is a realm of constant innovation, where the development of new technologies has the power to transform...
- Sep 9
- 2 min
UK Responsible Person (UKRP): Obligations for Medical Device Manufacturers Outside the UK
For medical device manufacturers located outside the United Kingdom (UK) without local business offices, it is mandatory to designate a...
- Sep 8
- 4 min
Navigating Switzerland's Medical Device Regulations: The Role of Swiss Authorized Representatives
The Mutual Recognition Agreement (MRA) had been a pivotal instrument in fostering bilateral trade between Switzerland and the European...
- Sep 6
- 4 min
Meeting EU Regulations: The Role of the European Authorized Representative (EAR)
When foreign medical device and IVD manufacturers seek to distribute their devices within the European Union (EU) Member States,...
- Aug 28
- 5 min
Biologics and Biosimilar Regulations and Registration in the European Union (EU) (EMA)
In 2022, the Europe biosimilar market had a value of almost USD 4601.56 million. In addition, it is anticipated that the biosimilar...
- Aug 1
- 7 min
Pharmaceutical Regulations in European Union
The European pharmaceutical market is expected to reach USD 432.12 billion by 2028, growing at a CAGR of 5.4%. Cancer therapeutics is...
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